A psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) versus goal setting and routine care: a single-masked, phase 3, superiority, randomised controlled trial

Claudia Cooper; Victoria Vickerstaff; Julie Barber; Rosemary Phillips; Margaret Ogden; Kate Walters; Iain Lang; Penny Rapaport; Vasiliki Orgeta; Kenneth Rockwood; Sara Banks; Marina Palomo; Laurie T Butler; Kathyrn Lord; Gill Livingston; Sube Banerjee; Jill Manthorpe; Briony Dow; Juanita Hoe; Rachael Hunter; Quincy Samus; Jessica Budgett

doi:10.1016/S2666-7568(23)00262-3

A psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) versus goal setting and routine care: a single-masked, phase 3, superiority, randomised controlled trial

Lancet Healthy Longev. 2024 Feb;5(2):e141-e151. doi: 10.1016/S2666-7568(23)00262-3.

Authors

Claudia Cooper¹, Victoria Vickerstaff², Julie Barber³, Rosemary Phillips⁴, Margaret Ogden⁴, Kate Walters², Iain Lang⁵, Penny Rapaport⁶, Vasiliki Orgeta⁶, Kenneth Rockwood⁷, Sara Banks⁸, Marina Palomo⁶, Laurie T Butler⁹, Kathyrn Lord¹⁰, Gill Livingston⁶, Sube Banerjee¹¹, Jill Manthorpe¹², Briony Dow¹³, Juanita Hoe¹⁴, Rachael Hunter², Quincy Samus¹⁵, Jessica Budgett⁸

Affiliations

¹ Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University London, London, UK. Electronic address: claudia.cooper@qmul.ac.uk.
² Research Department of Primary Care and Population Health, University College London, London, UK.
³ Department of Statistical Science, University College London, London, UK.
⁴ Research Network Volunteer, Alzheimer's Society, London, UK.
⁵ St Luke's Campus, University of Exeter, Exeter, UK.
⁶ Division of Psychiatry, University College London, London, UK.
⁷ Division of Geriatric Medicine, Dalhousie University, Halifax, NS, Canada.
⁸ Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University London, London, UK.
⁹ Faculty of Science and Engineering, Anglia Ruskin University, Chelmsford, UK.
¹⁰ Centre for Applied Dementia Studies, University of Bradford, Bradford, UK.
¹¹ Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
¹² The Policy Institute at King's, King's College London, London, UK.
¹³ National Ageing Research Institute, Melbourne, VIC, Australia.
¹⁴ Geller Institute of Ageing and Memory, School of Biomedical Sciences, University of West London, London, UK.
¹⁵ Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.

Abstract

Background: Although national guidelines recommend that everyone with dementia receives personalised post-diagnostic support, few do. Unlike previous interventions that improved personalised outcomes in people with dementia, the NIDUS-Family intervention is fully manualised and deliverable by trained and supervised, non-clinical facilitators. We aimed to investigate the effectiveness of home-based goal setting plus NIDUS-Family in supporting the attainment of personalised goals set by people with dementia and their carers.

Methods: We did a two-arm, single-masked, multi-site, randomised, clinical trial recruiting patient-carer dyads from community settings. We randomly assigned dyads to either home-based goal setting plus NIDUS-Family or goal setting and routine care (control). Randomisation was blocked and stratified by site (2:1; intervention to control), with allocations assigned via a remote web-based system. NIDUS-Family is tailored to goals set by dyads by selecting modules involving behavioural interventions, carer support, psychoeducation, communication and coping skills, enablement, and environmental adaptations. The intervention involved six to eight video-call or telephone sessions (or in person when COVID-19-related restrictions allowed) over 6 months, then telephone follow-ups every 2-3 months for 6 months. The primary outcome was carer-rated goal attainment scaling (GAS) score at 12 months. Analyses were done by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN11425138.

Findings: Between April 30, 2020, and May 9, 2021, we assessed 1083 potential dyads for eligibility, 781 (72·1%) of whom were excluded. Of 302 eligible dyads, we randomly assigned 98 (32·4%) to the control group and 204 (67·5%) to the intervention group. The mean age of participants with dementia was 79·9 years (SD 8·2), 169 (56%) were women, and 133 (44%) were men. 247 (82%) dyads completed the primary outcome, which favoured the intervention (mean GAS score at 12 months 58·7 [SD 13·0; n=163] vs 49·0 [14·1; n=84]; adjusted difference in means 10·23 [95% CI 5·75-14·71]; p<0·001). 31 (15·2%) participants in the intervention group and 14 (14·3%) in the control group experienced serious adverse events.

Interpretation: To our knowledge, NIDUS-Family is the first readily scalable intervention for people with dementia and their family carers that improves attainment of personalised goals. We therefore recommend that it be implemented in health and care services.

Funding: UK Alzheimer's Society.

Publication types

Randomized Controlled Trial
Clinical Trial, Phase III

MeSH terms

Aged
Aged, 80 and over
Behavior Therapy
Caregivers / psychology
Dementia* / therapy
Female
Goals
Humans
Male